UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055648 |
|---|---|
| Receipt number | R000063476 |
| Scientific Title | Evaluation of health function of cooked rice with emulsified formulation(2):Influence on blood sugar level of the rice which added lecithin included in the rice:Study of eating the test meal for two week. |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2025/02/12 14:37:23 |
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Basic information
Public title
Evaluation of health function of cooked rice with emulsified formulation(2):Influence on blood sugar level of the rice which added lecithin included in the rice: Study of eating the test meal for two week.
Acronym
Influence on blood sugar level of the rice which added lecithin included in the rice: Study of eating the test meal for two week.
Scientific Title
Evaluation of health function of cooked rice with emulsified formulation(2):Influence on blood sugar level of the rice which added lecithin included in the rice:Study of eating the test meal for two week.
Scientific Title:Acronym
Influence on blood sugar level of the rice which added lecithin included in the rice: Study of eating the test meal for two week.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Accessing the glycemic response to the rice with emulsified formulation including rice bran oil. The subject eats test meal for two weeks. we investigate their blood suger levels for before and after the 2 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycoalbumin, blood sugar level, HbA1c, insulin
Key secondary outcomes
Blood triglyceride level, Blood total GLP-1 and GIP levels, Anthropometric tests, blood biochemical tests, and hematologic tests
<Exploratory outcomes>
Brief-type self-administrated diet history questionnaire (BDHQ), Eating behavior questionnaire Continuous glucose monitor, Sensory questionnaire, Body Composition analysis by DEXA method
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
With the first, the subjects eat the rice meal which applied the lecithin which it be crowded and made from oil 150 g of once twice a day. they continue this for two weeks. they attach CGM for ten days of the beginning and check a change of the blood sugar level. We collect blood before and after intervention and check a change.
They eat stable rice meal with the same point for a washout period of 3 weeks.
With the second, they eat stable rice meal 150 g of once twice a day, and continue this for two weeks.THey attach CGM for ten days of the beginning and check a change of the blood sugar level.We collect blood before and after intervention and check a change.
Interventions/Control_2
With the first, the subjects eat stable rice meal 150 g of once twice a day, they continue this for two weeks. they attach CGM for ten days of the beginning and check a change of the blood sugar level. We collect blood before and after intervention and check a change.
They eat stalbe rice meal with the same point for a washout period of 3 weeks.
With the second, they eat the rice which applied the lecithin which it be crowded and made from oil 150 g of once twice a day, and continue this for two weeks.THey attach CGM for ten days of the beginning and check a change of the blood sugar level.We collect blood before and after intervention and check a change.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The one where a written agreement is provided in hope of clinical study participation voluntarily
2) The person who can maintain an everyday lifestyle during testing period constantly
Key exclusion criteria
1.The one that is infected with a serious disease (diabetes, heart trouble, liver disease, renal disease, cancer) and mental disease
2.The disease (diabetes, heart trouble, liver disease, renal disease, cancer) that is serious in the past with a history of the past
3.The that did the blood donation more than 400 mL within 150 mL or three months during the past one month
4.The person who has experienced poor feeling and physical condition aggravation by drawing blood in the past, the which, also, it has been said to that drawing blood was difficult because blood vessel was thin
5.One with the high anemia symptom
6.The person who a meal and the change of the momentum are big, and cannot maintain an everyday lifestyle
7.Food allergy for the examination food, the drug allergy which is thought about
8.The person who eats a food for specified health use, a health food routinely
9.In addition, the one where an examination responsibility doctor disqualified participation in final examination
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrision University
Division name
Nutrition Crinic
Zip code
1708481
Address
3-24-3, Komagome, Toshima-ku, Tokyo
TEL
0339186181
clinic@eiyo.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kamachi |
Organization
Kagawa Nutrition University
Division name
Nutrition Clinic
Zip code
1708481
Address
3-24-3 Komagome,Toshima-ku, Tokyo.
TEL
0339186181
Homepage URL
clinic@eiyo.ac.jp
Sponsor or person
Institute
Kagawa Nutrition University
Institute
Department
Personal name
Funding Source
Organization
NARO Bio-oriented Technoligy Reseach Advancement Institution
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Human Research Ethics Commitee of Kagawa University
Address
3-9-21,Chiyoda, Sakado-chi, Saitama
Tel
0492896041
kenshien@eiyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063476
